Trial Outcomes & Findings for Comparison of Injection Site Pain Experience for Semaglutide and Dulaglutide sc (NCT NCT04189848)
NCT ID: NCT04189848
Last Updated: 2022-11-07
Results Overview
The intensity of injection site pain was measured on a visual analogue scale (VAS). The VAS consists of a horizontal 100 millimeters (mm) line where 0 mm corresponded to no pain and 100 mm corresponded to unbearable pain. After each injection, the participants rated their pain perception at the VAS by marking a vertical line across the 100 mm horizontal line. The distance (mm) between the endpoint "no pain" and the vertical line on the VAS was recorded and analysed.
COMPLETED
PHASE4
104 participants
1 minute after each injection (Day 1)
2022-11-07
Participant Flow
The trial was conducted at one site in the Netherlands.
Participants were randomised in a 2×2 scheme evenly to 4 sequences (A, B, C and D) of semaglutide product (Semaglutide 1.34 mg/mL PDS290 pre-filled pen-injector) or dulaglutide product (Trulicity 0.75 mg solution for injection in pre-filled pen) and side of injection (right/left) on abdomen.
Participant milestones
| Measure |
Sequence A: Semaglutide (Right) Then Dulaglutide (Left)
Participants were to receive a subcutaneous (s.c.) injection of 0.25 milligrams (mg) of semaglutide on the right side of abdomen (in treatment period 1); followed by an s.c. injection of 0.75 mg of dulaglutide product on the left side of abdomen (in treatment period 2). The 2 products were administered on the same day (Day 1) with at least 30 minutes apart from each other.
|
Sequence B: Semaglutide (Left) Then Dulaglutide (Right)
Participants were to receive an s.c. injection of 0.25 mg of semaglutide on the left side of abdomen (in treatment period 1); followed by an s.c. injection of 0.75 mg of dulaglutide on the right side of abdomen (in treatment period 2). The 2 products were administered on the same day (Day 1) with at least 30 minutes apart from each other.
|
Sequence C: Dulaglutide (Right) Then Semaglutide (Left)
Participants were to receive an s.c. injection of 0.75 mg of dulaglutide on the right side of abdomen (in treatment period 1); followed by an s.c. injection of 0.25 mg of semaglutide on the left side of abdomen (in treatment period 2). The 2 products were administered on the same day (Day 1) with at least 30 minutes apart from each other.
|
Sequence D: Dulaglutide (Left) Then Semaglutide (Right)
Participants were to receive an s.c. injection of 0.75 mg of dulaglutide on the left side of abdomen (in treatment period 1); followed by an s.c. injection of 0.25 mg of semaglutide on the right side of abdomen (in treatment period 2). The 2 products were administered on the same day (Day 1) with at least 30 minutes apart from each other.
|
|---|---|---|---|---|
|
Treatment Period 1 (Day 1)
STARTED
|
26
|
26
|
25
|
27
|
|
Treatment Period 1 (Day 1)
COMPLETED
|
26
|
26
|
25
|
27
|
|
Treatment Period 1 (Day 1)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Treatment Period 2 (Day 1)
STARTED
|
26
|
26
|
25
|
27
|
|
Treatment Period 2 (Day 1)
COMPLETED
|
26
|
26
|
25
|
27
|
|
Treatment Period 2 (Day 1)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Injection Site Pain Experience for Semaglutide and Dulaglutide sc
Baseline characteristics by cohort
| Measure |
Overall Study
n=104 Participants
Participants were to receive s.c. injections of 0.25 mg semaglutide and 0.75 mg dulaglutide each from any of the sequences A/B/C/D on Day 1. The 2 products were administered at least 30 minutes apart from each other.
|
|---|---|
|
Age, Continuous
|
36.9 years
STANDARD_DEVIATION 17.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
62 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
104 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White + Black or African
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
94 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White + Asian
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 minute after each injection (Day 1)Population: The per protocol (PP) set included all participants who had received both injections of semaglutide and dulaglutide and had completed both intensity of injection site pain assessments.
The intensity of injection site pain was measured on a visual analogue scale (VAS). The VAS consists of a horizontal 100 millimeters (mm) line where 0 mm corresponded to no pain and 100 mm corresponded to unbearable pain. After each injection, the participants rated their pain perception at the VAS by marking a vertical line across the 100 mm horizontal line. The distance (mm) between the endpoint "no pain" and the vertical line on the VAS was recorded and analysed.
Outcome measures
| Measure |
Semaglutide
n=104 Participants
Participants were to receive an s.c. injection of 0.25 mg of semaglutide on either (left or right) sides of abdomen in any of the sequences A/B/C/D on Day 1.
|
Dulaglutide
n=104 Participants
Participants were to receive an s.c. injection of 0.75 mg of dulaglutide on either (left or right) sides of abdomen in any of the sequences A/B/C/D on Day 1.
|
|---|---|---|
|
Intensity of Injection Site Pain
|
5.6 Score on a scale
Standard Deviation 10.1
|
11.5 Score on a scale
Standard Deviation 12.8
|
Adverse Events
Overall Study
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Overall Study
n=104 participants at risk
Participants were to receive s.c. injections of 0.25 mg semaglutide and 0.75 mg dulaglutide each from any of the sequences A/B/C/D on Day 1. The 2 products were administered at least 30 minutes apart from each other.
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
21.2%
22/104 • Number of events 23 • Day 1 to Day 28. Results are based on the safety analysis set which included all participants who had received at least 1 injection of semaglutide or dulaglutide (included any skin contact with trial product whether the injection was completed or not).
All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset date on or after the day of first injection and no later than 28 days after the day of last injection. The trial was crossover and injections were given only 30 minutes apart. Therefore it was not possible to say which product the AE was related to. Hence, AE data are presented for the overall study.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
11.5%
12/104 • Number of events 12 • Day 1 to Day 28. Results are based on the safety analysis set which included all participants who had received at least 1 injection of semaglutide or dulaglutide (included any skin contact with trial product whether the injection was completed or not).
All presented adverse events are treatment emergent adverse events (TEAEs). TEAE was defined as an event that had onset date on or after the day of first injection and no later than 28 days after the day of last injection. The trial was crossover and injections were given only 30 minutes apart. Therefore it was not possible to say which product the AE was related to. Hence, AE data are presented for the overall study.
|
Additional Information
Clinical Reporting Anchor and Disclosure (1452)
Novo Nordisk A/S
Results disclosure agreements
- Principal investigator is a sponsor employee At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.
- Publication restrictions are in place
Restriction type: OTHER